Change in Fatigue Severity Score [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]

Change in Fatigue Severity Score from baseline to end of four weeks of treatment

Secondary Outcome Measures:

Additional questionnaire will be used to quantify fatigue, quality of life, symptoms of depression, sleep quality, virologic, immunologic, and inflammatory markers. [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]

Change in the Brief Fatigue Inventory from baseline to end of four weeks of treatment

Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]

Change in Epworth Sleepiness Scale score from baseline to end of four weeks of treatment

Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]

Change in Patient Health Questionnaire score from baseline to end of four weeks of treatment

Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]

Change in Insomnia Severity Index Score from baseline to end of four weeks of treatment

Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]

Change in Medical Outcomes Study HIV Health Survey score from baseline to end of four weeks of treatment

Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]

Change in Clinical Global Impressions of Change Scale score from baseline to end of four weeks of treatment

Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]

Change in IL-6 and soluble receptors of TNF α 1 and 2 (sTNFR1 and sTNFR2) from baseline to end of four weeks of treatment

Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: Yes ]

Change in CD4 cell count from baseline to end of four weeks of treatment

Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to end of four weeks of treatment ] [ Designated as safety issue: Yes ]

Change in plasma HIV RNA from baseline to end of four weeks of treatment

Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to end of four weeks of treatment ] [ Designated as safety issue: Yes ]

Adverse events in intervention (American ginseng) and control arms (placebo) from baseline to end of four weeks of treatment

Additional questionnaire will be used to quantify fatigue, inflammatory, immunologic, and virologic markers, and side effects [ Time Frame: From baseline to the end of four weeks of treatment ] [ Designated as safety issue: No ]

Change in PROMIS fatigue score from baseline to end of four weeks of treatment

American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Other Name: Panax quinquefolius

Placebo Comparator: Placebo for American ginseng 1000 mg/day

4-week of placebo for American ginseng 1000 mg/day every morning

Dietary Supplement: Placebo for American ginseng

Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Other Name: Placebo for American ginseng

Active Comparator: American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

Drug: American ginseng

American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Other Name: Panax quinquefolius

Placebo Comparator: Placebo for American ginseng 3000 mg/day

4-week of placebo for American ginseng 3000 mg/day every morning

Dietary Supplement: Placebo for American ginseng

Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

HIV-1 infection documented by a rapid HIV test or any licensed ELISA test kit and confirmed by a repeat ELISA, Western blot at any time prior to study entry; or documentation of ongoing HIV/AIDS care, or treatment for AIDS, or previous positive HIV serology at any time prior to study entry

NOTE: If the potential subject is taking an atazanavir-containing regimen at the time of screening, total bilirubin ≤5 x ULN is acceptable

* Calculation for the Cockcroft-Gault equation is available at https://www.fstrf.org/common/utilities/calculators/ccc.html

Clinically significant fatigue (≥4.5 on the FSS)

PHQ-9 Questionnaire score <10

ISI Questionnaire <14

On stable psychiatric medications for at least 8 weeks prior to enrollment.

Ability and willingness of subject to provide a signed informed consent and comply with all study requirements

Laboratory values and physical examination as judged by the principal investigator to be safe to participate

Females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy or tubal ligation) will need a negative serum or urine pregnancy test within 30 days prior to entry.

All potential subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/ partner must reliable methods of contraception (condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormone-based contraceptive) while receiving study treatment. Subjects will be encourage to use a barrier method of contraception (e.g. condoms) along with hormonal contraceptives during administration of American ginseng.

As determined by the investigator, history of chronic or acute medical condition that in the opinion of the investigator would jeopardize safety of subjects participating in this study

Hospitalization or therapy for serious illness within 30 days prior to study entry as judged by the investigator

Known allergy/sensitivity or any hypersensitivity to components of American ginseng

Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence or subject compliance with study requirements (stable methadone treatment allowed)

Current use or requirement for any medications prohibited with study treatment including warfarin. (Lists of prohibited medications are contained in the Prohibited Medications Section of the protocol)

Pregnancy or breastfeeding

Use of any immunomodulator (e.g., interferons, interleukins, systemic corticosteroids, cyclosporine), vaccine, or investigational therapy within 30 days prior to study entry

Treatment with investigational study drugs/vaccines

Co-enrolment in observational trials is allowed if the blood volume requirement does not exceed the Red Cross limits specified for this clinical trial

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500096